Image

Effects of Flumazenil on Recovery After Total Intravenous Anesthesia With Remimazolam

Recruiting
65 years of age
Both
Phase N/A

Powered by AI

Overview

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil. In clinical situations, the use of flumazenil for the reversal of sedation is common, but there is no precise indication for its administration. In this study, we aim to investigate the necessity of routine flumazenil use after administering remimazolam for intravenous anesthesia.

Description

Remimazolam is a medication that has the advantage of a short half-life and reversibility with flumazenil.

Although there are advantages of using flumazenil, such as reduced recovery time and decreased occurrence of postoperative cognitive dysfunction (POCD), it can cause rebound sedation, ventricular arrhythmias, seizures, agitation, and gastrointestinal symptoms. Therefore, routine administration is not recommended.

However, in actual clinical situations, it is common to use flumazenil as a routine reversal agent for benzodiazepines, but there is no research on the routine use of flumazenil for reversing the effects of remimazolam in anesthesia or sedation.

Factors such as obesity, advanced age, and low plasma albumin concentration can prolong the time for extubation during anesthesia with remimazolam. Therefore, when considering the routine use of flumazenil in waking patients using remimazolam in elderly patients, these factors should be taken into account. However, there is also no specific indication for its accurate administration.

Therefore, this study aims to investigate the effects of flumazenil on recovery after total intravenous anesthesia with remimazolam in elderly patients undergoing hip joint surgery

Eligibility

Inclusion Criteria:

  • Patients over 65 years old scheduled for hip joint surgery

Exclusion Criteria:

  • Patients with impaired consciousness or delirium before surgery
  • Patients who are hemodynamically unstable before surgery
  • Patients with a history of neurological or neuromuscular disorders or use of medications that affect neurological or neuromuscular function
  • Patients who have taken sedatives (anti-anxiety medications, antipsychotics, antidepressants, sleep aids) within the past 24 hours
  • Patients with known allergy to benzodiazepine, flumazenil
  • Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
  • Patients with hypersensitivity to Dextran40
  • Patients who have been taking benzodiazepine for long term
  • Patients with end stage renal disease requiring hemodialysis
  • Patients with history of acute angle glaucoma
  • Patients with alcohol or substance dependence
  • ASA classification 4 or 5

Study details

Flumazenil Adverse Reaction, Remimazolam, Hip Joint, Elderly Patients

NCT05939674

Pusan National University Yangsan Hospital

26 January 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.